Device And Method For Improving Function Of Heart Valve

ABSTRACT

A device for improving the function of a heart valve comprises a first loop-shaped support, which is configured to abut a first side of the heart valve, and a first flange unit being connected to said first loop-shaped support. The flange unit is configured to be arranged against said annulus when said first loop-shaped support is abutting said heart valve.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/719,107 filed May 21, 2015 entitled Device And Method For ImprovingFunction Of Heart Valve, which is a continuation of U.S. patentapplication Ser. No. 13/525,093 filed Jun. 15, 2012 entitled Device AndMethod For Improving Function Of Heart Valve, now U.S. Pat. No.8,734,507 issued May 27, 2014, which is a divisional of U.S. patentapplication Ser. No. 12/514,795 filed Jan. 19, 2010 entitled Device AndMethod For Improving Function Of Heart Valve, now U.S. Pat. No.8,663,322 issued Mar. 4, 2014, which claims priority to InternationalPatent Application No. PCT/EP2007/062225, International Filing Date 12Nov. 2007, entitled Device And Method For Improving Function Of HeartValve, which claims priority to Swedish Provisional Application No.0602421-0 filed Nov. 13, 2006, and U.S. Provisional Application SerialNo. 60/876,123 filed Dec. 21, 2006, all of which are hereby incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention pertains in general to the field of repair ofheart valves having various malformations and dysfunctions. Morespecifically, the invention relates to heart valve repair techniques andprocedures involving annuloplasty devices.

BACKGROUND OF THE INVENTION

Diseased mitral and tricuspid valves frequently need replacement orrepair. The mitral and tricuspid valve leaflets or supporting chordaemay degenerate and weaken or the annulus may dilate leading to valveleak, i.e. an insufficiency of valve function. The leaflets and chordsmay become calcified and thickened rendering them stenotic, whichimplies obstructing a forward flow through the valve. Finally, the valverelies on insertion of the chordae inside the ventricle. If theventricle changes in shape, the valve support may become non-functionaland the valve may leak.

Mitral and tricuspid valve replacement and repair are traditionallyperformed with a suture technique.

During valve replacement, sutures are spaced around the annulus, i.e.the point where the valve leaflet attaches to the heart, and then thesutures are attached to a prosthetic valve. The prosthetic valve islowered into position and when the sutures are tied, the prostheticvalve is fastened to the annulus. The surgeon may remove all or part ofthe valve leaflets before inserting the prosthetic valve.

In valve repair, a diseased valve is left in situ and surgicalprocedures are performed to restore its function. Frequently anannuloplasty ring is used to reduce the size of the annulus. Theannuloplasty ring serves to reduce the diameter of the annulus andallows the leaflets to oppose each other normally, thus restoring valvefunction. Sutures are used to attach the prosthetic annuloplasty ring tothe annulus and to assist in placating the annulus.

In general, the annuloplasty rings and replacement valves must besutured to the valve annulus and this is time consuming and tedious.Moreover, if the annuloplasty ring is severely malpositioned, then thestitches must be removed by the surgeon, and the ring repositionedrelative to the valve annulus during restitching. In other cases, a lessthan optimum annuloplasty may be tolerated by the surgeon rather thanlengthening the time of the surgery to restitch the ring.

During heart surgery, a premium is placed on reducing the amount of timeused to replace and repair valves as the heart is frequently arrestedand without perfusion. In e.g. U.S. Pat. No. 6,368,348, an annuloplastyprosthesis is disclosed for supporting an annulus of a heart valve. Theprosthesis is devised to be stitched to the annulus of the heart thusremodeling the same. It would therefore be very useful to have animproved method, procedure, and/or device providing an efficientattachment of a prosthesis into the mitral or tricuspid valve position.

For instance in US 2002/0173841 and in U.S. Pat. No. 6,419,696, whichare assigned to the same applicant as the present application, anannuloplasty device is disclosed. The annuloplasty device comprises afirst and a second support ring, which are connected to each other toform a coiled configuration. The first and second support rings arearranged to abut opposite sides of a valve annulus to trap valve tissuebetween them. This annuloplasty device may be easily applied to thevalve by rotating the device into position on opposite sides of thevalve annulus. To ensure a proper and lasting fixation to the valveannulus such device can be fixated by barbs, retaining members,interlocking portions, fasteners or locking elements, all beingintegrated in the device. Fixation can also be made by means ofsuturing.

In WO 2006/091163, which are assigned to the same applicant as thepresent application, a device for improving the function of a heartvalve is disclosed that comprises a first loop- shaped support, which isconfigured to abut a first side of the heart valve, and a secondloop-shaped support, which is configured to abut a second side of theheart valve opposite to said first side, whereby a portion of the valvetissue is trapped between the first and second supports. An outerboundary of the second support is greater than an outer boundary of thefirst support. An annuloplasty instrument for implantation of the abovementioned device is disclosed in WO 2006/054930 by the same applicant asthe present application. Thus deployment of the device in WO 2006/091163is facilitated. These two above mentioned comprise a kit to be usedtogether for the treatment of heart valve deficiencies. Paravalvularleakage is not addressed in these disclosures.

In U.S. Pat. No. 4,042,979 an adjustable valvuloplasty ring is disclosedthat comprises a C-shaped frame that is sized and shaped to extend aboutthe circumference of the left atrioventricular orifice along the base ofthe anterior cusp of the mitral valve; an expandable sleeve connected tothe frame that together therewith forms a closed annulus, the sleevebeing adapted to extend about the remainder of the circumference of theorifice; and a drawstring running through the sleeve by which the sleevemay be contracted to constrict and remodel the orifice and secured inplace to maintain such constriction.

However, the prosthetic devices disclosed in the above mentioneddocuments might be further improved for a more convenient, fasterpositionable, and/or even more reliable device and method of valverepair and valve replacement. It is a specific object of the inventionto provide a device, which allows for an easy and durable fixation tothe valve annulus.

Furthermore, an improvement that is desired to be provided by improveddevices and methods comprises allowing a prevention or minimization ofbackflow of blood, e.g. passing by or underneath the prosthetic devicesof the prior art.

Hence, an improved annuloplasty device and medical procedure would beadvantageous and in particular allowing for increased flexibility,cost-effectiveness, convenience and speed of positioning, increasedreliability and/or patient safety would be advantageous.

OBJECTS AND SUMMARY OF THE INVENTION

An object of the invention is to provide an improved medical device andmethod of valve repair and valve replacement. Another object of theinvention may be to provide an annuloplasty device, which allows for aneasy and durable fixation to the valve annulus.

Accordingly, embodiments of the present invention preferably seek tomitigate, alleviate or eliminate one or more deficiencies, disadvantagesor issues in the art, such as the above-identified, singly or in anycombination by providing a medical device and a method according to theappended patent claims.

According to a first aspect of the invention, there is provided amedical device for improving the function of a heart valve comprised ofvalve tissue including an annulus and a plurality of leaflets, thedevice comprising: a first loop-shaped support, which is configured toabut a first side of the heart valve, and a first flange unit (or flangeelement or flange means) being connected to said first loop-shapedsupport, and which is configured to be arranged against said annuluswhen said first loop-shaped support is abutting said heart valve.

This device may be used to perform annuloplasty, that is to reshape thevalve annulus, in order to improve the function of the valve. The flangeunit provides a well defined surface to be used when fixating the deviceagainst the annulus no matter if the device in use is positionedabutting the atrial or the ventricle side of annulus.

This implies that the device may easily be fixated to the annulus in aspeedy manner. This is of importance since during heart surgery, apremium is placed on reducing the amount of time used to replace andrepair valves as the heart is frequently arrested and without perfusion.

Also, the flange unit may provide for a sealing surface against saidannulus allowing prevention of backflow of blood from the ventricle sideto the atrial side.

Further, the provision of a flange unit implies that a smooth transitionsection may be formed between the outer periphery of the device andannulus.

Further, a well defined surface for attachment of fixating means such assutures or clips may be provided. A smooth transition section as well asa well defined attachment surface are two parameters of importance for asmooth formation and growth of endothelia.

In addition, the flange unit may be used for carrying or fixation of aprosthetic valve.

The device may further comprise a second loop-shaped support, which isconfigured to abut a second side of the heart valve opposite to saidfirst side, whereby a portion of the valve tissue is trapped between thefirst and second supports. The trapping of valve tissue between thefirst and second loop-shaped supports implies that the desired shape ofthe valve, both natural or prosthetic, may be fixated. Further, thetrapping implies that the device may temporarily be kept in correctposition while fixating the device permanently to an annulus by means ofe.g. sutures or clips.

The first loop-shaped support may be formed continuously with the secondloop-shaped support to form a substantially coil-shaped body. Thisimplies that the device and its coil-shape may be applied at acommissure between the leaflets of the heart valve and be rotatedapproximately 360° such that one loop-shaped support is inserted throughthe commissure to extend along one side of the valve and the otherloop-shaped support is arranged along the opposite side of the valve.Thus, valve tissue will be trapped between the supports to fixate adesired shape of the valve. Depending on the extension of the flangemeans, the latter may provide an attachment surface on one of or on bothsides of the annulus for fixation of the device.

The first flange unit may extend from the first loop-shaped support tothe second loop-shaped support, whereby the flange unit may beconfigured to be arranged against the annulus on opposite sides of thevalve tissue being trapped between the first and second supports. Thisimplies that the flange unit may form a flange surface on both sides ofthe annulus or heart valve, which surface may provide for fixation, notonly of the device but also of a prosthetic valve. Further, the flangeunit may form a sealing surface that, depending on the position of thedevice, allows reduction or prevention of possible backflow of bloodfrom the ventricle side to the atrial side.

The second loop-shaped support may comprise a second flange unit beingconnected thereto, which flange unit may be configured to be arrangedagainst the annulus on a side thereof being opposite the firstloop-shaped support when the second loop-shaped support is abutting theheart valve. This allows prevention of paravalvular leakage.

At least one of the first and second flange unit may be adapted to forma connection of at least one of the loop-shaped supports and aprosthetic valve against the annulus. This implies a rapid fixation,which is of importance since during heart surgery a premium is placed onreducing the time required.

At least one of the first and second flange unit may have anintermittent or continuous extension along the periphery of itscorresponding loop-shaped support. By way of example, in case of anintermittent extension the flange unit may be formed by two localsections diametrically opposing each other, whereby the two sections,when the device is positioned in the heart valve, are abutting thecommissures forming a sealing surface thereto.

At least one of the first and second flange units may be made of afabric material. The fabric material may be a woven material. A fabrichas the advantage that it presents a rough surface enhancing ingrowth oranchoring of endothelia. Further, a fabric is easily penetrated bysutures or clips. Also, a fabric allows the flange unit to be easilyconformed to the annulus.

The fabric material may be impregnated with or integrate apharmaceutical agent further improving embodiments of the devices andmethod. The pharmaceutical agent may for instance be an antiinflammatory, stenos preventing, or endotheliazation promoting agent.

Further, at least one of the first and second flange unit may comprise areinforcing element. The reinforcing element provides an indication anddefinition of an area in which clips or sutures are to be put whenfixating the medical device to the annulus. Further, the reinforcingelement contributes to reducing the risk of pockets being formed alongthe circumferential surface. Also, the element prevents unthreading ofthe fabric in the flange.

At least one of the first and second flange unit may protrude or extendout from and form an angle a (see e.g. FIG. 5) of approximately 30-60°,such as e.g. approximately 40-50° below a diametric plane formed by oneof the loop-shaped supports. By the flange unit initially extendingbelow the diametric plane, the visibility during insertion is enhanced.In some embodiments, during insertion, the flange unit due to inherentflexibility may be fold, e.g. upwards in FIG. 5, even fold back over itspoint of fixation relative the diametric plane, or above the diametricplane with an outer edge of the flange unit. The point of fixation of atleast one of the flange unit may be fixed in relation to the diametricplane, radially outward from at least one of the loop-shaped supports.

The flange unit may protrude with other angles, even in a fold back,i.e. more than 90°. This may be during or prior to a time of use orimplantation thereof. The angle may be variable over time, e.g. to theherein described shape memory effect of some embodiments of the flangeunit.

The flange unit may in some embodiments be arranged to change shapeduring insertion, e.g. by a resilient arrangement thereof. The flangeunit may also be made of a shape memory material that returns to apre-defined shape of form during insertion of the medical device, e.g.by a temperature triggered effect as known in the art of shape memorymaterials.

At least one of the first and second flange unit extends radiallyinwards or outwards from its corresponding loop-shaped support. Aradially inward extension provides a support for the valve leaflets,whereas a radially outward extension provides a support against theannulus. The first side of the heart valve is the atrial side and thesecond side is the ventricle side.

According to a second aspect of the invention there is provided a methodfor repairing a heart valve comprised of valve tissue including anannulus and a plurality of leaflets for allowing and preventing bloodflow, the method comprising: inserting a device comprising at least oneloop-shaped support and at least one flange unit being connected to theloop-shaped support to a heart valve, positioning the loop-shapedsupport such that it abuts a first side of the heart valve, positioningthe flange unit such that it abuts the annulus, and fixating the deviceby attaching the flange unit to the annulus.

The advantages provided by a device having a flange unit have previouslybeen discussed above. The inventive method for repairing a heart valveuses a corresponding device, whereby at least the same benefits areachieved.

The flange unit may be attached to the annulus by using sutures orclips, which allows for a quick and easy fixation using well establishedmeans. Alternatively, or in addition, barb elements or tissue adhesivesmay be used for the attachment to the annulus.

The provision of a flange unit implies that a smooth transition sectionmay be formed between the outer periphery of the device and annulus.Further, the flange unit presents a well defined and easy detectablesurface for attachment of the clips or sutures. A smooth transitionsection as well as a well defined attachment surface allows for a smoothformation and growth of endothelia. Endothelia formation may further beimproved by an endotheliazation agent.

The flange unit may be conformed to the annulus before fixating thedevice. By conforming the flange unit, the transition section may beadditionally smoothened, further enhancing growth of endothelia.

The device may be inserted to the heart valve by using a catheter,whereupon the catheter is withdrawn leaving the device.

In the method the first side of the heart valve may be the atrial side.

Further, in another aspect, the invention provides a kit comprising adevice for improving the function of a heart valve comprised of valvetissue including an annulus and a plurality of leaflets, the devicecomprising: a first loop-shaped support, which is configured to abut afirst side of the heart valve, and a first flange unit being connectedto the first loop-shaped support, and which is configured to be arrangedagainst the annulus when the first loop-shaped support is abutting theheart valve, and an artificial valve.

This device may be used in a medical procedure to perform annuloplasty,that is to reshape the valve annulus, in order to improve the functionof the valve. The flange unit provides a well defined surface to be usedwhen fixating the device against the annulus. This implies that thedevice may be fixated to the annulus very easily and in a speedy manner.The latter is of importance since during heart surgery, a premium isplaced on reducing the amount of time used to replace and repair valvesas the heart is frequently arrested and without perfusion. Also, theflange unit provides a sealing surface against the annulus allowingprevention of backflow of blood from the ventricle side to the atrialside. By the device carrying an artificial prosthetic valve, the stepsand time involved when performing the surgery may be reduced. Further,the positioning of such prosthetic valve in relation to the annulus isfacilitated.

The device may further comprise a second loop-shaped support, which isconfigured to abut a second side of the heart valve opposite to thefirst side, whereby a portion of the valve tissue is trapped between thefirst and second supports. The trapping of valve tissue between thefirst and second loop-shaped supports implies that the desired shape ofthe valve may be fixated. Further, the trapping implies that the devicemay temporarily be kept in correct position while substantially fixatingthe device permanently to an annulus by means of e.g. sutures or clips.

The first loop-shaped support may be continuous with the secondloop-shaped support to form a coil-shaped body. This implies that thedevice and its coil-shape may be applied at a commissure between theleaflets of the heart valve and be rotated 360° such that oneloop-shaped support is inserted through the commissure to extend alongone side of the valve and the other loop-shaped support being arrangedalong the opposite side of the valve. Thus, valve tissue will be trappedbetween the supports to fixate a desired shape of the valve. Dependingon the extension of the flange means, the latter may provide anattachment surface on one of or on both sides of annulus for fixation ofthe device.

The first flange unit may extend from the first loop-shaped support tothe second loop-shaped support, whereby the flange unit may beconfigured to be arranged against the annulus on opposite sides of thevalve tissue being trapped between the first and second supports. Thisimplies that the flange unit may form a surface on both sides of theheart valve, which surface may be used for fixation, not only of thedevice but also of a prosthetic valve. Further, the flange unit may forma sealing surface that, depending on the position of the device, allowsprevention of possible backflow of blood from the ventricle side to theatrial side.

The second loop-shaped support may comprise a second flange unit beingconnected thereto, which flange unit may be configured to be arrangedagainst the annulus on a side thereof being opposite the firstloop-shaped support when the second loop-shaped support is abutting theheart valve. This allows prevention of paravalvular leakage.

At least one of the first and second flange unit may have anintermittent or continuous extension along the periphery of itscorresponding loop-shaped support. By way of example, in case of anintermittent extension the flange unit may be formed by two localsections diametrically opposing each other, whereby the two sections,when the device is positioned in the heart valve, are abutting thecommissures forming a sealing surface thereto.

At least one of the first and second flange unit may be made of a fabricmaterial. A fabric has the advantage that it presents a rough surfaceenhancing growth of endothelia. Further, a fabric is easily penetratedby sutures or clips. Also, a fabric allows the flange unit to be easilyconformed to the annulus.

Further, at least one of the first and second flange unit may comprise areinforcing element. The element provides an indication and definitionof the area in which clips or sutures are to be put when fixating thedevice to the annulus. Further, the element reduces the risk of pocketsbeing formed along the circumferential surface. Also, the elementprevents unthreading of the fabric in the flange.

At least one of the first and second flange unit may extend out from andform an angle of 30-60°, such as 40-50° below a diametric plane formedby one of the loop-shaped supports. By the flange unit initiallyextending below the diametric plane, the visibility during insertion isenhanced.

At least one of the first and second flange unit may extend radiallyinwards or outwards from its corresponding loop-shaped support.

The artificial prosthetic valve may be arranged on one of theloop-shaped supports. In the case the device is intended to be insertedto the heart from the atrial side, the artificial valve is preferablyarranged on the support intended to be positioned on the atrial side ofannulus and vice verse.

Further, in another aspect, the invention may relate to a method forreplacing a heart valve comprised of valve tissue including an annulusand a plurality of leaflets for allowing and preventing blood flow, themethod comprising: inserting a device comprising an artificial valve, atleast a loop-shaped support and at least one flange unit being connectedto the loop-shaped support to a heart valve, positioning the loop-shapedsupport such that it abuts a first side of the heart valve, positioningthe flange unit such that it abuts the annulus, and fixating the deviceby attaching the flange unit to the annulus.

The advantages provided by a device having a flange unit and anartificial valve have previously been discussed above. The inventivemethod for replacing a heart valve uses a corresponding device, wherebythe same benefits are achieved.

The flange unit may be attached to the annulus by using suitablefixation units, e.g. sutures or clips, which allows for a quick fixationusing well established means.

The flange unit may be conformed to the annulus before fixating thedevice. By conforming the flange to the annulos the surface to becovered by endothelia is reduced, allowing the growth to be enhanced andaccelerated.

The device may be inserted to the heart valve by using a catheter,whereupon the catheter is withdrawn leaving the device.

In the method, the first side of the heart valve is preferably theatrial side.

The artificial valve may be arranged on one of said loop-shapedsupports.

Further embodiments of the invention are defined in the dependentclaims, wherein features for the second and subsequent aspects of theinvention are as for the first aspect mutatis mutandis.

Some embodiments of the invention provide for a reduced amount of timeused to repair and/or replace cardiac valves.

Some embodiments of the invention also provide for a reduced orprevented backflow of blood, e.g. by a smooth transition section may beformed between the outer periphery of the device and annulus.

Some embodiments of the invention provide for a more convenient repair,e.g. by means of a well defined surface for attachment of fixating meanssuch as sutures or clips.

Some embodiments of the invention provide for a smooth formation andgrowth of endothelia.

It should be emphasized that the term “comprises/comprising” when usedin this specification is taken to specify the presence of statedfeatures, integers, steps or components but does not preclude thepresence or addition of one or more other features, integers, steps,components or groups thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which embodiments ofthe invention are capable of will be apparent and elucidated from thefollowing description of embodiments of the present invention, referencebeing made to the accompanying drawings, in which

FIG. 1 schematically illustrates a patient with a heart shown incross-section and a device of an embodiment of the present inventionschematically illustrated as supporting the mitral valve;

FIG. 1A is a cross-sectional view of the left ventricle showing themitral valve in perspective;

FIG. 2 is a perspective view of a body of a device according to a firstembodiment of the invention;

FIG. 3 is a cross-sectional view of the body in FIG. 2;

FIG. 4 is a perspective view of the first embodiment of the devicecomprising the body shown in FIG. 2;

FIG. 5 is a cross-sectional view of the device in FIG. 4;

FIG. 6 is a perspective view of a second embodiment of the device;

FIG. 7 is a perspective view of a third embodiment of the device;

FIG. 8 is a perspective view of a fourth embodiment of the device;

FIG. 9a, 9b are perspective views that illustrate insertion of anembodiment of the device;

FIG. 10 is a cross-sectional view showing an embodiment of the deviceinserted in a heart valve;

FIGS. 11 and 12 are schematic illustrations that show a heart valvebefore and after remodeling by using the device;

FIG. 13 is a cross sectional view that shows the device fixed to theannulus;

FIG. 14a is a cross sectional view that shows a first embodiment of thedevice comprising an artificial prosthetic heart valve;

FIG. 14b is a cross sectional view that shows a second embodiment of thedevice comprising an artificial valve;

FIG. 15 is a cross-sectional view of an alternative device having oneloop-shaped support carrying the flange unit;

FIG. 16a, 16b are cross sectional views of embodiments involving a shapechange; and

FIG. 17 is a cross sectional view schematically illustrating a flangeunit having barb elements for affixing to tissue.

DESCRIPTION OF EMBODIMENTS

Specific embodiments of the invention will now be described withreference to the accompanying drawings. This invention may, however, beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will be thorough and complete, and willfully convey the scope of the invention to those skilled in the art. Theterminology used in the detailed description of the embodimentsillustrated in the accompanying drawings is not intended to be limitingof the invention. In the drawings, like numbers refer to like elements.

FIG. 1 illustrates a patient 10 having a heart 12 shown in cross-sectionincluding a left ventricle 14 and a right ventricle 16. The concepts ofthe present invention are suitable to be applied, for example, to amitral valve 18 which supplies blood into left ventricle 14. Mitralvalve 18, as better shown in FIG. 1A, includes an annulus 20 and a pairof leaflets 22, 24 which selectively allow and prevent blood flow intoleft ventricle 14. It will be appreciated that the term valve tissue isused extensively throughout this disclosure in reference to thedrawings. The inventive principles are equally applicable when referringto any valve tissue such as annulus tissue, leaflet tissue or otherattached vessel tissue. Leaflets 22, 24 are supported for coaptation bychordae tendinae or chords 26, 28 extending upwardly from respectivepapillary muscles 30, 32. Blood enters left ventricle 14 through mitralvalve 18 and is expelled during subsequent contraction of heart 12through aortic valve 34. It will be appreciated that the presentinvention is applicable to tricuspidal heart valves as well.

A body 41 comprised in a device 40 according to a first embodiment ofthe present invention is shown in FIGS. 2 and 3. The body 41 comprises afirst and a second loop-shaped support 42, 44.

As used herein, the term “loop-shaped” should be construed as a curvedshape that may be closed, as at least a part of a ring with e.g. acircular, elliptic, or D-shaped form or any other closed form which mayfit the shape of the valve annulus. The term “loop-shaped” also includesa curved shape that is open forming an arcuate shape, such as a C-shapeor U-shape, which includes an angular turn of at least 180° such thatthe support may abut valve tissue along a major part of the annularvalve shape. The term “loop-shaped” also includes a curved shapeoverlapping itself to form a portion of a coil.

The term “loop-shaped” also includes three dimensional curves asmentioned in the previous paragraph.

The loop shape of at least a part of at least one of the supports 42, 44may also in some embodiments be patient configured. The shape may bedesigned specifically to an anatomy of a patient. The patient specificloop shape may be virtually derived from 3D patient data, e.g. acquiredby image modalities, such as Magnetic Resonance (MR) or ComputerTomography (CT) Imaging.

In U.S. Pat. Nos. 6,419,696, 6,730,121, 6,964,684, and WO 2006/091163,which are assigned to the same applicant as the present invention andincorporated by reference herein in their entirety for all purposes,devices are disclosed for repairing and replacing a heart valve invarious embodiments. The devices include at least first and secondsupport rings connected together in loop-shaped configurations to abutopposite sides of a valve annulus. A replacement valve may be secured tothe loop-shaped devices.

The first support 42 may be continuous and/or integral with the secondsupport 44 such that the supports 42, 44 assume a coiled configurationin the form of a spiral or keyring-type configuration with two loops.

The second support 44 may have an outer boundary or extent which isgreater in relation to the outer boundary of the first support 42. Thesupports 42, 44 may in an embodiment have corresponding shapes with thesecond support 44 being in larger scale than the first support 42. Thisis advantageous in creating a pinch of the valve tissue between thefirst 42 and second supports 44.

An end 45 of the second support 44, which will lead the coil duringinsertion of the device at the valve, may in an embodiment have agreater pitch than the rest of the coil. This implies that the leadingend 45 of the coil during rotation into position in the valve willproject from immediate contact with the valve tissue and, therefore, therisk that the coil is caught by the chords is diminished.

The body 41 is shown in cross-section in FIG. 3. The body 41 has in anembodiment at least partly a round cross-sectional shape. In otherembodiments, the cross section of the body 41 may be substantially flat,oval, flattened and/or have flattened edges.

In embodiments, the opposed surfaces 46 thus provide a pinch to trapvalve tissue there between. A round cross-section is also advantageousin creating a pinch of the valve tissue which will not harm the leafletsin their movement during normal heart action.

The second loop-shaped support 44 is slightly displaced radially withrespect to the first loop-shaped support 42. This implies that the firstand second loop-shaped supports 42, 44 are not arranged directly on topof each other in some embodiments. The pinch between the first 42 andsecond supports 44 is therefore not sharply defined in a radialdirection of the valve. This implies that a pinching force between thesupports is not focused to a specific radial position of the valve. As aresult, the pinching force does not affect the movement of the leafletsduring normal heart action and there is a diminished risk of rupture inthe leaflets at the pinch.

The supports may in some embodiments be interrelated in such manner thatthe outer boundary of the first support 42 has a diameter correspondingto a line through the centre of the second support 44. Thus, thesupports 42, 44 may overlap somewhat such that tissue is not allowed tomove through the pinch and the shape of the valve is maintainedadvantageously.

Further, the cross-section of the supports 42, 44 is substantiallyround, which also gives a soft contact between the supports and thevalve tissue to further diminish the risk of rupture in the leaflets.

The body 41 may be formed from a core of a rigid material, such as ametal, e.g., titanium, or plastic. Any suitable medical gradematerial(s) may be used.

The rigid material may provide a passive spring function such that theloops of the coil may be forced a small distance away from each otherbut will flex back towards each other when the force is released. Thecore of the body 41 may be coated by a softer layer, such as a textile.

The body 41 may alternatively be formed from a shape memory material.The body 41 will then assume a desired, programmed shape, when e.g.heated to a specific temperature. This allows the body 41 to becompressed or straightened of the form better suited for deliveringduring insertion and to assume a spiral shape when inserted at the heartvalve. Also, the flange unit may be made of such a shape memorymaterial, e.g. to provide a first, delivery shape and a second,delivered shape thereof.

Now turning to FIGS. 4 and 5, a first embodiment of the medical device40 is disclosed. The device 40 comprises a body 41 in accordance withthat described above with reference to FIGS. 2 and 3, whereby the body41 as such is not further discussed.

The device 40 comprises a flange unit 50 being connected to the body 41and more precisely to the first loop-shaped support 42. The flange unit50 has in an embodiment a continuous extension along the periphery ofthe first loop-shaped support 42.

In some embodiments, the flange unit 50 may be integral with at least aportion of the body 41, as e.g. shown in FIG. 16 a.

In some embodiments the flange unit 50 is made of a tube shaped flexiblematerial 52 being passed onto the first loop-shaped support 42, wherebya loose substantially co-axial connection between the loop-shapedsupport and the flange unit is achieved. The connection may also befixed or rigid. The flexible material may by way of example be a fabricor woven structure made of Polyethylene (PE) or polytetrafluoroethylene(PTFE). A fabric has the advantage that it presents a rough, holed orporous surface enhancing growth of and overgrowth of endothelia.Further, a fabric is easily penetrated by sutures or clips. In addition,the flexible material admits the flange unit 50 to be conformed to theannulus.

The flange unit 50 does in the disclosed embodiment form a flangesurface 54 extending downwards out from the body. More precisely theflange unit 50 forms in some embodiments and angle a to a horizontal,diametric plane formed by the first loop-shaped support. The angle a isapproximately between 30-60°, such as 40-50° to the diametric plane.Such angle improves the visibility during insertion of the device. Insome embodiments, improved visibility may be provided during insertionof the device, whereupon the flange unit 50 changes shape to a positionfacilitating fixation thereof to surrounding tissue. Thus, medicalprocedures for heart valve repair and/or replacement may be speeded upconsiderably.

In a practical embodiment the flange surface 54 has a width in the rangeof approximately 2-4 mm such as 2.5-3.5 mm. The width of the flangeradially outwards allows an indication for the surgeon of the area inwhich sutures or clips should be positioned when fixating the device tothe annulus. This is further discussed below with reference to FIG. 13.

Initially, before inserted into the heart valve, the flange surface 54extends downwardly. When positioned in the atrial side of the heartvalve, the device will be arranged abutting the annulus whereby theflange unit will be conformed to the annulus, changing its angle fromextending downwardly to extending upwardly. This ability to conform is acombination of the flexibility of the (fabric) material and the width ofthe flange means.

On its outer periphery, the flange unit 50 may comprise a reinforcingelement 65, which is schematically illustrated in FIG. 4. Suchreinforcing element may by way of example have the form of a thread 65 aor a bead 65 b.

Now turning to FIG. 6, a second embodiment of the device 40 isdisclosed. The device differs from that disclosed in FIGS. 4 and 5 inthat the flange unit 50 extends from the first loop-shaped support 42 tothe second loop-shaped support 44. The flange unit 50 may be formed inone piece or be separated into a first and a second piece, wherein thefirst piece is connected to the first loop-shaped support and the secondpiece is connected to the second loop-shaped support. The connection maybe a rigid connection or a loose connection. The latter may be achievedby the flange unit being passed onto the loop-shaped support(s).

The flange unit may be continuous or intermittent along its extension.

The second embodiment is suitable no matter if the device is to be usedfor repairing or replacing a valve.

Now turning to FIG. 7, a third embodiment of the device 40 is disclosed.The device 40 differs from that disclosed in FIGS. 4 and 5 in that theflange unit 50 extends along the second loop-shaped support 44. Whenpositioned in the heart valve, the second loop-shaped support 44 isintended to abut the ventricle side of the heart valve, whereas thefirst loop-shaped support 42 is intended to abut the atrial side. Theflange unit 50 may be continuous or intermittent along its extension.The third embodiment may be suitable when used in valve replacement. Anartificial, i.e. prosthetic valve may be carried by either the body orthe flange means.

Now turning to FIG. 8, a fourth embodiment of the device 40 isdisclosed. The device 40 differs from that disclosed in FIGS. 4 and 5 inthat the flange unit 50 extends along the second loop-shaped support 44and forms two flange surfaces 54, both being connected to the secondloop-shaped support 44. The flange surfaces 54 are so arranged on theloop-shaped support 44 that they overlap the commissures when the deviceis arranged in the heart valve abutting the annulus. Thereby the twoflange surfaces form a sealing preventing possible leakage of blood fromthe ventricle side to the atrial side.

In the above discussed embodiments of the device, the flange unit hasbeen disclosed as being either continuous or intermittent along itsextension. The flange unit may further have a non-uniform width varyingalong its extension. By way of example the width may be larger in aregion corresponding to a position overlapping the commissure when thedevice is arranged in the heart valve abutting the annulus.

Referring now to FIGS. 9-11, a method for repairing a heart valve bymeans of the device according to the first embodiment will be described.

First, access to the heart valve is achieved by conventional techniques,including arresting the heart and opening the chest. Alternatively, anintraluminal catheter based delivery technique may be applied. In FIG.9a , the device 40 is shown when being inserted to the mitral valve 18from the atrial side. The device 40 is being carried on a carrier ortool (not shown), which is connected to a stem for remote control of thepositioning of the carrier. An end 56 of the second loop-shaped support44 is brought to the opening of the mitral valve 18 at a commissure 60between the leaflets 22, 24, as shown in FIG. 9b . The end 56 is ledthrough the opening and the carrier is turned 360 degrees. Thus, thesecond support 44 will be rotated into place on one side of the valve18, whereas the first support 42 and the flange unit is placed on theopposite side of the valve 18. During this rotational movement theflange unit 50 is deflected from its original direction forming an angleof 30-60° downwards from the diametric plane formed by the support 42 toa direction extending in an angle upwards from the diametric planecorresponding to the wall formed by the annulus 20. The deflectionallowed by the flexibility of the flange unit 50 results in a closeabutment between the flange unit 50 and the atrial side of the annulus20. If necessary, the flange unit 50 may be additionally conformed tothe annulus 20. In this way, the device 40 is arranged in engagementwith the valve 18, as shown in FIG. 10.

Further, the supports 42, 44 are placed on opposite sides of the valve18 pinching valve tissue between them to maintain a shape of the valve18. The leaflets 22, 24 may now be drawn towards each other through thepinch of the support rings 42, 44 so as to remodel the shape of thevalve 18. The leaflets may be drawn through the pinch by means of aforceps instrument. The supports 42, 44 may flex away from each other toallow drawing leaflets 22, 24 through the pinch and towards each otherfor preventing the leaflets 22, 24 to slip back. The valve annulus 20may in this way be remodeled and the new shape is maintained by thesupports 42, 44, see FIGS. 11 and 12 showing before and afterremodeling. In FIG. 11 a defective closure region 400 of the valveleaflets 22, 24 is shown. The supports 42, 44 may have roughened,opposed surfaces 46 to better keep the leaflets 22, 24 from slippingthrough the pinch and to hold the valve annulus 20 in its reshaped form.

The device 40 may now be secured to the valve 18 for strengthening thefixation of the relative position between the supports 42, 44 and thevalve tissue, see FIG. 13. The fixation may be made by clips or sutures62 which are arranged through the flange unit 50 and its circumferentialflange surface 54. By the latter being made of fabric it is easilypenetrated. The clips or sutures 62 are preferably oriented andpositioned in the circumferential direction of the flange unit 50. Thenumber of fixation points is arbitrary for the provision of a durablefixation.

The flange unit 50 provides in some embodiments a better seat andprevents sliding of the device 40. Thus, the device 40 is positionedmore stable in the procedure, which is advantageous, especially forlong-term performance of the device after insertion.

As illustrated in FIG. 10, the second support 44 is slightly displacedradially with respect to the first support 42. This implies that thefirst and second supports 42, 44 are not arranged directly on top ofeach other. The pinch between the first and second supports is thereforenot sharply defined in a radial direction of the valve. This impliesthat a pinching force between the supports is not focused to a specificradial position of the valve. As a result, the pinching force does notaffect the movement of the leaflets during normal heart action and thereis a diminished risk of rupture in the leaflets at the pinch. Thesupports are interrelated in such manner that the outer boundary of thefirst support 42 has a diameter corresponding to a line through thecentre of the second support 44. Thus, the supports 42, 44 overlapsomewhat such that tissue is not allowed to move through the pinch andthe shape of the valve is maintained. Further, the cross-section of thesupports 42, 44 is round, which also gives a soft contact between thesupports and the valve tissue to further diminish the risk of rupture inthe leaflets.

The method described above is applicable no matter the shape, positionor extension of the flange means. Further, the method is applicable nomatter if the device is inserted from the atrial side or the ventricleside.

A device having a flange unit on the first, upper loop-shaped support issuitable when the device is to be positioned on the atrial side,providing a fixation surface to the atrial side of the annulus. Suchdevice is also suitable when carrying an artificial valve. Further, adevice having a flange unit on the second loop-shaped support issuitable when the second loop-shaped support is to be positioned on theventricle side of the heart valve.

A device having a flange unit extending from the first to the secondloop-shaped support is suitable no matter if the device is positioned onthe atrial side or the ventricle side of the heart valve.

With reference to FIG. 14a and FIG. 14b , it is to be understood thatthe device may be used for replacement of heart valves as well. For thatpurpose the device 40 comprises in addition to a body 41 and a flangeunit 50 an artificial valve 64. The flange unit 50 may be carried by thefirst loop shaped support 42 as is shown in FIG. 14a . Alternatively, asis shown in FIG. 14b , the flange unit 50 may extend from the first 42to the second 44 support. Although not shown, it is to be understoodthat each support 42, 44 may carry its own flange unit 50, or that theflange unit may be carried by the second support 44 only.

The method of inserting, positioning and fixation of the device isgenerally the same as that used when repairing a heart valve, wherebythe method as such is not further discussed.

It should be emphasized that the preferred embodiments described hereinare in no way limiting and that many alternative embodiments arepossible within the scope of protection defined by the appended claims.

By way of example, the device 40 and its body 41 has been disclosed ashaving a first 42 and a second 44 loop-shaped support. The device 40 isapplicable with only one loop-shaped support carrying the flange unit50. One such embodiment is disclosed in FIG. 15.

Further, the access to the heart valve may be achieved endoscopically,or transluminally, catheter based. In such case, the device 40 needs tobe inserted through a narrow tube (endoscope or catheter). This impliesthat the device 40 will need to be compressed during insertion in orderto pass through the endoscope or catheter. The device 40 needs to assumeits proper shape after having been passed through the endoscope.Therefore, using an endoscopic or catheter based approach, the body mayadvantageously be formed from a shape memory material. This allows thedevice 40 to be compressed and also to have a stable shape when beingapplied to the heart valve. In the alternative, where the access to theheart valve may be achieved through a catheter, which is passed throughthe vascular system to the heart. In this case, the supports may beformed from a shape-memory material, which during insertion extendsalong the catheter in a flexible state and, when pushed out of thecatheter at the heart valve, assumes a pre-stressed coil-shape in orderto abut the heart valve on opposite sides.

The first and second loop-shaped supports may be connected to each otherby means of a connecting part so as to form a coil-shape. The coil-shapeof the device is advantageous during insertion, since the device maythen be rotated into position, as described above. However, theconnecting part is detachable from at least one of the supports. Thus,when the device has been inserted, the connecting part may be detachedand removed from the opening of the valve.

The loop-shaped support(s) and the flange unit may be provided asseparate parts.

Further, it is to be understood that the flange means, or at least awing part thereof, may form an arbitrary angle to its correspondingloop-shaped support.

FIG. 16a, 16b are cross sectional views of embodiments involving a shapechange.

In FIG. 16a the change of shape of a flange unit 50 is illustrated, e.g.for being out of a line of sight for a surgeon during insertion (dottedline) and, when in contact with body tissue, turning to a second shape(continuous line) for attaching to the tissue.

In FIG. 16a the change of shape of a flange unit 50 is illustrated intwo steps or directions. Firstly the flange unit may shrink in a firstdirection, in order to eliminate any wrinkles or folds therein.Subsequently or concurrently, the flange unit 50 may change shape in asecond direction, e.g. as described with reference to FIG. 16 a.

FIG. 17 is a cross sectional view schematically illustrating a flangeunit 50 having barb elements 500 for affixing the device 40 to tissue.The flange unit 50 may thus be a carrier for fixation elements. Theflange unit 50 may thus be inserted into the body more effectively.

In some embodiments, different materials may be used for parts of thedevice 40. For instance, the inner rings 42, 44 may be made of a stiffermore stable than a more flexible outer part, e.g. the flange unit 50.

While several embodiments of the present invention have been describedand illustrated herein, those of ordinary skill in the art will readilyenvision a variety of other means and/or structures for performing thefunctions and/or obtaining the results and/or one or more of theadvantages described herein, and each of such variations and/ormodifications is deemed to be within the scope of the present invention.More generally, those skilled in the art will readily appreciate thatall parameters, dimensions, materials, and configurations describedherein are meant to be exemplary and that the actual parameters,dimensions, materials, and/or configurations will depend upon thespecific application or applications for which the teachings of thepresent invention is/are used.

Those skilled in the art will recognize, or be able to ascertain usingno more than routine experimentation, many equivalents to the specificembodiments of the invention described herein. It is, therefore, to beunderstood that the foregoing embodiments are presented by way ofexample only and that, within the scope of the appended claims andequivalents thereto, the invention may be practiced otherwise than asspecifically described and claimed. The present invention is directed toeach individual feature, system, article, material, kit, and/or methoddescribed herein. In addition, any combination of two or more suchfeatures, systems, articles, materials, kits, and/or methods, if suchfeatures, systems, articles, materials, kits, and/or methods are notmutually inconsistent, is included within the scope of the presentinvention as limited by the appended patent claims.

1. (canceled)
 2. A system comprising a medical device comprising: afirst loop-shaped support, which is configured to abut a first side of anative heart valve, a second loop-shaped support, which is configured toabut a second side of the native heart valve opposite to said firstside, wherein an end of the second loop-shaped support is configured tobe inserted through a natural opening of the heart valve formed betweenleaflets at a commissure of the leaflets, wherein the first loop-shapedsupport is continuous with the second loop-shaped support to form acoil-shaped body configured to be rotated into place so that a portionof native heart valve tissue is trapped between the first and secondloop-shaped supports, a heart valve prosthesis adapted to be carried bythe first loop-shaped support or the second loop-shaped support when thefirst and second loop-shaped supports are positioned in abutment withthe native heart valve.
 3. System according to claim 2, wherein theheart valve prosthesis is adapted to be arranged on the firstloop-shaped support or on the second loop-shaped support.
 4. Systemaccording to claim 2, wherein the medical device comprises a flangeunit.
 5. System according to claim 4, wherein the heart valve prosthesisis adapted to be attached to the flange unit.
 6. System according toclaim 4, wherein the flange unit is adapted to form a connection of atleast one of the loop-shaped supports and the heart valve prosthesisagainst an annulus of the native heart valve.
 7. System according toclaim 4, wherein the flange unit is connected to the first loop-shapedsupport and/or the second loop shaped support.
 8. System according toclaim 4, wherein the flange unit is adapted to provide a sealing surfaceagainst an annulus of the native heart valve when the first and secondloop-shaped supports are positioned in abutment with the native heartvalve.
 9. System according to claim 4, wherein the flange unit flangeunit comprises barb elements for affixing the medical device to tissue.10. System according to claim 2, wherein the first loop-shaped supportis adapted to abut an atrial side of the native heart valve and thesecond loop-shaped support is adapted to abut a ventricular side of thenative heart valve, wherein an outer boundary of the second loop-shapedsupport is greater than an outer boundary of the first loop-shapedsupport.
 11. System according to claim 2, wherein the second loop-shapedsupport is displaced radially with respect to the first loop-shapedsupport.
 12. System according to claim 2, wherein said end of the secondloop-shaped support have a greater pitch than the rest of thecoil-shaped body.
 13. System according to claim 2, wherein the medicaldevice comprises a shape memory material.